HemophiliaNCT07420387
Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy
A study testing Educational group in people with Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Hemophilic arthropathy is a common complication of hemophilia, characterized by chronic pain, functional limitation, and impaired quality of life. Cognitive-emotional factors such as catastrophizing and kinesiophobia significantly influence the pain experience, supporting the rationale for interventions… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Educational group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2026to 11 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with a confirmed diagnosis of hemophilia A or B.
- Presence of hemophilic arthropathy.
- Presence of chronic pain.
Who cannot join
- Patients with neurological or cognitive impairments that preclude understanding of the educational sessions.
- Patients who have undergone surgical intervention within the two months preceding the educational program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad de Oviedo
Oviedo, Principality of Asturias, 33006
Rubén Cuesta-Barriuso, PhD, 0034 985 103 386, cuestaruben@uniovi.es
About this study
Official title: Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy: A Randomized Controlled Trial
Introduction: Hemophilic arthropathy is a common complication of hemophilia, characterized by chronic pain, functional limitation, and impaired quality of life. Cognitive-emotional factors such as catastrophizing and kinesiophobia significantly influence the pain experience, supporting the rationale for interventions grounded in the biopsychosocial model and pain neuroscience education.
Objective: To evaluate the efficacy of an educational program based on pain neurobiology, emotional regulation, and cognitive-behavioral strategies on the pain experience in adult patients with hemophilic arthropathy.
Read more
Methods: A randomized, controlled clinical trial with two parallel groups (intervention and control) and three assessment time points (pre-intervention, post-intervention, and 6-month follow-up) will be conducted. A total of 70 adult patients with hemophilia A or B and a diagnosis of hemophilic arthropathy with chronic pain will be enrolled and randomly assigned in a 1:1 ratio. The intervention group will receive a structured educational program consisting of three 60-minute sessions focused on pain neurobiology, emotional regulation, cognitive restructuring, coping strategies, and physiological downregulation techniques, including supervised physical activity as an analgesic strategy. The control group will continue with usual care without additional educational intervention. The primary outcome will be pain intensity and pain interference, assessed using the Brief Pain Inventory. Statistical analyses will be performed using repeated-measures ANOVA, with the Group × Time interaction considered the primary effect of interest, under the intention-to-treat principle.
Expected Results: It is anticipated that the intervention group will demonstrate a statistically and clinically significant reduction in pain intensity and pain-related functional interference compared with the control group. A sustained clinical improvement at six months is also expected, supporting the utility of structured educational interventions as a safe and complementary strategy in the management of chronic pain in patients with hemophilic arthropathy.
- Conditions
- Hemophilia
- Being tested
- Educational group
- Keywords
- Hemophilia, Hemophilic arthropathy, Chronic pain, Pain neuroscience education
- Medical subject headings
- Hemophilia A, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational groupOther
Patients with hemophilia will receive a structured pain education program delivered through targeted educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients with hemophilia allocated to the intervention group will receive a structured pain education program delivered through targeted educational sessions. Receives: Other: Educational group |
| Control group | No intervention | Participants allocated to the control group will not receive physiotherapy sessions based on pain education and will continue with their usual routine of physical activity and exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Pain Severity and Pain-Related Interference in Daily Life
Pain severity and pain-related interference in daily life will be assessed using the Spanish version of the Brief Pain Inventory (BPI). This instrument evaluates both the intensity of pain and its impact on daily functioning, including general activity, ambulation, usual work, mood, sleep, social relationships, and enjoyment of life. It provides separate scores for pain severity and pain interference, with higher scores indicating greater pain intensity or greater perceived functional impact
Measured: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Secondary outcomes (6)
Measurement of Kinesiophobia
This variable will be assessed using the Spanish version of the Tampa Scale for Kinesiophobia (TSK). This scale evaluates kinesiophobia, defined as an excessive and irrational fear of movement and physical activity associated with the expectation of pain or injury. The instrument provides a total score reflecting the degree of fear-avoidance related to movement, with higher scores indicating greater levels of kinesiophobia.
Measured: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Pain Catastrophizing
This variable will be assessed using the Spanish version of the Pain Catastrophizing Scale (PCS). This instrument measures pain catastrophizing, defined as a negative cognitive-affective response to actual or anticipated pain. The questionnaire evaluates dimensions such as rumination, magnification, and helplessness, providing a total score in which higher values reflect a greater degree of catastrophizing thinking.
Measured: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Health-Related Quality of Life
This variable will be assessed using the Spanish version of the Short Form-36 Health Survey (SF-36). This instrument evaluates health-related quality of life and consists of 36 items covering eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health, including one health transition item. A specific score is calculated for each domain, with higher values indicating a better perceived health status. Scores range from 0 to 100 for each dimension.
Measured: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Anxiety
This variable will be assessed using the Spanish version of the Hospital Anxiety and Depression Scale (HADS). This questionnaire evaluates anxiety symptomatology in clinical populations, providing a specific score for the anxiety subscale, with higher values indicating a greater presence of anxious symptoms.
Measured: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Illness Perception
This variable will be assessed using the Spanish version of the Brief Illness Perception Questionnaire (BIPQ). This instrument evaluates illness perception, defined as the set of cognitive and emotional beliefs and representations that a patient holds regarding their disease. The questionnaire assesses dimensions such as perceived consequences, personal control, concern, illness coherence (understanding of the disease), and emotional response, yielding scores that reflect the degree of perceived illness threat.
Measured: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Physical Activity Level
This variable will be assessed using the International Physical Activity Questionnaire (IPAQ). This instrument evaluates the level of physical activity, allowing participants to be classified according to their activity level and enabling quantification of physical activity performed across different contexts. This variable will be included to describe the study sample and to explore its potential influence on pain perception and on the outcomes of the intervention.
Measured: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start27 Mar 2026 (estimated)
- Primary completion28 Jun 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, Investigación en Hemofilia y Fisioterapia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420387
- Sponsor's protocol ID
- HemoPain
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07420387
- Acronym / sponsor ID
- HemoPain
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Hemophilic arthropathy, Chronic pain, Pain neuroscience education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 27 Mar 2026 (estimated)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Hemophilic arthropathy is a common complication of hemophilia, characterized by chronic pain, functional limitation, and impaired quality of life. Cognitive-emotional factors such as catastrophizing and kinesiophobia significantly influence the pain experience, supporting the rationale for interventions grounded in the biopsychosocial model and pain neuroscience education.
Objective: To evaluate the efficacy of an educational program based on pain neurobiology, emotional regulation, and cognitive-behavioral strategies on the pain experience in adult patients with hemophilic arthropathy.
Methods: A randomized, controlled clinical trial with two parallel groups (intervention and control) and three assessment time points (pre-intervention, post-intervention, and 6-month follow-up) will be conducted. A total of 70 adult patients with hemophilia A or B and a diagnosis of hemophilic arthropathy with chronic pain will be enrolled and randomly assigned in a 1:1 ratio. The intervention group will receive a structured educational program consisting of three 60-minute sessions focused on pain neurobiology, emotional regulation, cognitive restructuring, coping strategies, and physiological downregulation techniques, including supervised physical activity as an analgesic strategy. The control group will continue with usual care without additional educational intervention. The primary outcome will be pain intensity and pain interference, assessed using the Brief Pain Inventory. Statistical analyses will be performed using repeated-measures ANOVA, with the Group × Time interaction considered the primary effect of interest, under the intention-to-treat principle.
Expected Results: It is anticipated that the intervention group will demonstrate a statistically and clinically significant reduction in pain intensity and pain-related functional interference compared with the control group. A sustained clinical improvement at six months is also expected, supporting the utility of structured educational interventions as a safe and complementary strategy in the management of chronic pain in patients with hemophilic arthropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Educational groupPatients with hemophilia allocated to the intervention group will receive a structured pain education program delivered through targeted educational sessions. |
| Control group | No intervention | –Participants allocated to the control group will not receive physiotherapy sessions based on pain education and will continue with their usual routine of physical activity and exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with a confirmed diagnosis of hemophilia A or B.
- Presence of hemophilic arthropathy.
- Presence of chronic pain.
Key exclusion criteria (2 listed)
- Patients with neurological or cognitive impairments that preclude understanding of the educational sessions.
- Patients who have undergone surgical intervention within the two months preceding the educational program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational groupPatients with hemophilia will receive a structured pain education program delivered through targeted educational sessions. | Other | Experimental group |
Primary outcome
Measurement of Pain Severity and Pain-Related Interference in Daily Life
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Pain severity and pain-related interference in daily life will be assessed using the Spanish version of the Brief Pain Inventory (BPI). This instrument evaluates both the intensity of pain and its impact on daily functioning, including general activity, ambulation, usual work, mood, sleep, social relationships, and enjoyment of life. It provides separate scores for pain severity and pain interference, with higher scores indicating greater pain intensity or greater perceived functional impact
6 secondary outcomes
Measurement of Kinesiophobia
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Pain Catastrophizing
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Health-Related Quality of Life
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Anxiety
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Illness Perception
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Physical Activity Level
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hemophilia
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational group in people with Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta-Barriuso, PhD (0034 985103386, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Pain Severity and Pain-Related Interference in Daily Life (time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.